Cardiopulmonary BypassNCT07508579
Effect of Hypothermia on BIS and PSI Correlation During Cardiopulmonary Bypass
An observational study of Cardiopulmonary Bypass and Hypothermia; Anesthesia, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate whether hypothermia affects the relationship between electroencephalography-derived indices during cardiac surgery in adult patients undergoing cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiopulmonary Bypass, Hypothermia; Anesthesia, Depth of Anesthesia Monitoring
- What is being tested?
- Simultaneous BIS and PSI Monitoring
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective on-pump coronary artery bypass grafting (CABG) with cardiopulmonary bypass at a single tertiary care center will be included. All participants will receive standard general anesthesia and perioperative management according to institutional protocols. Patients will be monitored intraoperatively with both Bispectral Index (BIS) and Patient State Index (PSI) devices, and data will be collected at predefined time points during normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass.
Who may be able to join
- Age ≥18 years
- Elective on-pump Coronary Artery Bypass Grafting (CABG) surgery
- Planned use of general anesthesia
- Written informed consent
Who cannot join
- Preexisting neurological disease
- Use of medications affecting Electroencephalography (e.g., antiepileptics)
- Severe hepatic dysfunction
- Emergency surgery
- Inadequate signal quality for anesthesia depth monitoring
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation
Sakarya, Serdivan
About this study
Official title: Effect of Hypothermia on the Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) During Cardiopulmonary Bypass
The goal of this observational study is to evaluate whether hypothermia affects the relationship between electroencephalography-derived indices during cardiac surgery in adult patients undergoing cardiopulmonary bypass.
The main questions it aims to answer are:
Read more
Does the correlation between Bispectral Index (BIS) and Patient State Index (PSI) change between normothermic and hypothermic phases during cardiopulmonary bypass? How do BIS and PSI values change in response to decreasing body temperature?
Participants will:
Undergo standard general anesthesia for elective on-pump coronary artery bypass surgery Be monitored simultaneously with BIS and PSI devices during surgery Have data recorded at predefined temperature-based time points during cardiopulmonary bypass
Read the detailed description
Hypothermia during cardiopulmonary bypass (CPB) is known to influence cerebral metabolism and electroencephalographic activity. Processed electroencephalography-derived indices such as the Bispectral Index (BIS) and Patient State Index (PSI) are commonly used to monitor anesthetic depth; however, these indices are generated using different proprietary algorithms. While previous studies have demonstrated moderate to high correlation between BIS and PSI under normothermic conditions, it remains unclear whether this relationship is preserved during hypothermic CPB.
This prospective observational study aims to evaluate the effect of hypothermia on the relationship between BIS and PSI in adult patients undergoing elective on-pump coronary artery bypass grafting. Both indices will be monitored simultaneously throughout the intraoperative period using standard sensor placement.
Data will be collected at predefined time points representing normothermic, hypothermic, and rewarming phases of CPB. The primary analysis will focus on comparing the correlation between BIS and PSI at a normothermic reference point (36°C) and a hypothermic reference point (32°C).
To minimize confounding effects, anesthetic management and physiological parameters will be maintained within routine clinical target ranges, and relevant variables will be recorded throughout the procedure. Secondary analyses will explore temperature-dependent changes in each index and agreement between clinically relevant depth-of-anesthesia categories.
This study is designed to clarify whether hypothermia alters the relationship between commonly used processed EEG indices, which may have implications for intraoperative neuromonitoring and anesthetic management during cardiac surgery.
- Being tested
- Simultaneous BIS and PSI Monitoring
- Keywords
- Bispectral Index, Patient State Index, Processed EEG, Cardiac Surgery, Hypothermic CPB, Depth of Anesthesia, Intraoperative Monitoring
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous BIS and PSI MonitoringOther
This observational study does not involve any experimental intervention. All participants will receive standard anesthesia and surgical care according to institutional protocols. The study focuses on simultaneous intraoperative monitoring using Bispectral Index (BIS) and Patient State Index (PSI) devices. Sensors for both monitors will be applied prior to induction of anesthesia, and values will be recorded at predefined time points during normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass. No changes will be made to routine clinical management, and all treatments will be determined by the attending anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| Elective On-Pump CABG Patients Undergoing CPB | Adult patients undergoing elective on-pump coronary artery bypass grafting with cardiopulmonary bypass will be included. All participants will receive standard general anesthesia and intraoperative management according to institutional protocols. Bispectral Index (BIS) and Patient State Index (PSI) will be monitored simultaneously throughout surgery. Data will be collected at predefined time points across normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass to evaluate the relationship between these indices under varying temperature conditions. Receives: Other: Simultaneous BIS and PSI Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) Under Normothermic and Hypothermic Conditions
The primary outcome is the difference in Pearson correlation coefficients between BIS and PSI measured at predefined normothermic (36°C) and hypothermic (32°C) phases during cardiopulmonary bypass. Correlation coefficients will be calculated separately for each phase and compared using Fisher z-transformation to determine whether hypothermia alters the relationship between these indices.
Measured: Intraoperative (during cardiopulmonary bypass at predefined time points)
Secondary outcomes (3)
Change in Bispectral Index (BIS) and Patient State Index (PSI) per Degree Celsius During Cooling and Rewarming
This outcome evaluates temperature-dependent changes in BIS and PSI during cooling and rewarming phases of cardiopulmonary bypass. The rate of change in each index per degree Celsius (Δindex/°C) will be calculated using repeated measurements across predefined temperature points. Linear mixed-effects models will be used to estimate the relationship between core temperature and index values while accounting for within-subject variability.
Measured: Intraoperative (during cooling and rewarming phases of cardiopulmonary bypass)
Effect of CPB Initiation on the Relationship Between Bispectral Index (BIS) and Patient State Index (PSI)
This outcome assesses the impact of cardiopulmonary bypass initiation on the relationship between BIS and PSI. Pearson correlation coefficients will be calculated at the pre-CPB stable normothermic time point (T4) and after CPB initiation under normothermic conditions (T5). The change in correlation between these two time points will be evaluated to determine whether initiation of CPB alters the association between the indices.
Measured: Intraoperative (comparison of pre-CPB and post-CPB initiation time points)
Agreement in Clinical Depth Categories Between Bispectral Index (BIS) and Patient State Index (PSI)
This outcome evaluates the agreement between BIS and PSI when classified into clinically relevant depth-of-anesthesia categories. BIS values will be categorized as >60 (light), 40-60 (adequate), and <40 (deep), while PSI values will be categorized as >50 (light), 25-50 (adequate), and <25 (deep). Agreement between the two indices will be assessed using Cohen's kappa coefficient. Comparisons will be performed separately for normothermic and hypothermic phases to determine whether temperature affects categorical agreement.
Measured: Intraoperative (during predefined normothermic and hypothermic phases of cardiopulmonary bypass)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 May 2026
- Primary completion1 Aug 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Taş Tuna, Sakarya University
- Investigators
- AYÇA TAŞ TUNA, Professor, M.D., Principal investigator, Sakarya University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508579
- Sponsor's protocol ID
- SEAH-DOAonCPB-2026
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be shared upon reasonable request, subject to approval by the institutional ethics committee and in accordance with applicable data protection regulations. At the time of registration, a definitive data sharing plan has not been finalized.
Publications
Meybohm P, Gruenewald M, Hocker J, Renner J, Graesner JT, Ilies C, Scholz J, Bein B. Correlation and agreement between the bispectral index vs. state entropy during hypothermic cardio-pulmonary bypass. Acta Anaesthesiol Scand. 2010 Feb;54(2):169-75. doi: 10.1111/j.1399-6576.2009.02138.x. Epub 2009 Oct 15.
PubMed 19839944Belletti A, Lee DK, Yanase F, Naorungroj T, Eastwood GM, Bellomo R, Weinberg L. Changes in SedLine-derived processed electroencephalographic parameters during hypothermia in patients undergoing cardiac surgery with cardiopulmonary bypass. Front Cardiovasc Med. 2023 Jul 4;10:1084426. doi: 10.3389/fcvm.2023.1084426. eCollection 2023.
PubMed 37469479
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypothermia on the Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT07508579
- Acronym / sponsor ID
- SEAH-DOAonCPB-2026
- Keywords
- Bispectral Index, Patient State Index, Processed EEG, Cardiac Surgery, Hypothermic CPB, Depth of Anesthesia, Intraoperative Monitoring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate whether hypothermia affects the relationship between electroencephalography-derived indices during cardiac surgery in adult patients undergoing cardiopulmonary bypass.
The main questions it aims to answer are:
Does the correlation between Bispectral Index (BIS) and Patient State Index (PSI) change between normothermic and hypothermic phases during cardiopulmonary bypass? How do BIS and PSI values change in response to decreasing body temperature?
Participants will:
Undergo standard general anesthesia for elective on-pump coronary artery bypass surgery Be monitored simultaneously with BIS and PSI devices during surgery Have data recorded at predefined temperature-based time points during cardiopulmonary bypass
Detailed description
Hypothermia during cardiopulmonary bypass (CPB) is known to influence cerebral metabolism and electroencephalographic activity. Processed electroencephalography-derived indices such as the Bispectral Index (BIS) and Patient State Index (PSI) are commonly used to monitor anesthetic depth; however, these indices are generated using different proprietary algorithms. While previous studies have demonstrated moderate to high correlation between BIS and PSI under normothermic conditions, it remains unclear whether this relationship is preserved during hypothermic CPB.
This prospective observational study aims to evaluate the effect of hypothermia on the relationship between BIS and PSI in adult patients undergoing elective on-pump coronary artery bypass grafting. Both indices will be monitored simultaneously throughout the intraoperative period using standard sensor placement.
Data will be collected at predefined time points representing normothermic, hypothermic, and rewarming phases of CPB. The primary analysis will focus on comparing the correlation between BIS and PSI at a normothermic reference point (36°C) and a hypothermic reference point (32°C).
To minimize confounding effects, anesthetic management and physiological parameters will be maintained within routine clinical target ranges, and relevant variables will be recorded throughout the procedure. Secondary analyses will explore temperature-dependent changes in each index and agreement between clinically relevant depth-of-anesthesia categories.
This study is designed to clarify whether hypothermia alters the relationship between commonly used processed EEG indices, which may have implications for intraoperative neuromonitoring and anesthetic management during cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective On-Pump CABG Patients Undergoing CPB | – | Other: Simultaneous BIS and PSI MonitoringAdult patients undergoing elective on-pump coronary artery bypass grafting with cardiopulmonary bypass will be included. All participants will receive standard general anesthesia and intraoperative management according to institutional protocols. Bispectral Index (BIS) and Patient State Index (PSI) will be monitored simultaneously throughout surgery. Data will be collected at predefined time points across normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass to evaluate the relationship between these indices under varying temperature conditions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective on-pump coronary artery bypass grafting (CABG) with cardiopulmonary bypass at a single tertiary care center will be included. All participants will receive standard general anesthesia and perioperative management according to institutional protocols. Patients will be monitored intraoperatively with both Bispectral Index (BIS) and Patient State Index (PSI) devices, and data will be collected at predefined time points during normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Elective on-pump Coronary Artery Bypass Grafting (CABG) surgery
- Planned use of general anesthesia
- Written informed consent
Key exclusion criteria (5 listed)
- Preexisting neurological disease
- Use of medications affecting Electroencephalography (e.g., antiepileptics)
- Severe hepatic dysfunction
- Emergency surgery
- Inadequate signal quality for anesthesia depth monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous BIS and PSI MonitoringThis observational study does not involve any experimental intervention. All participants will receive standard anesthesia and surgical care according to institutional protocols. The study focuses on simultaneous intraoperative monitoring using Bispectral Index (BIS) and Patient State Index (PSI) devices. Sensors for both monitors will be applied prior to induction of anesthesia, and values will be recorded at predefined time points during normothermic, hypothermic, and rewarming phases of cardiopulmonary bypass. No changes will be made to routine clinical management, and all treatments will be determined by the attending anesthesiologist. | Other | Elective On-Pump CABG Patients Undergoing CPB |
Primary outcome
Difference in Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) Under Normothermic and Hypothermic Conditions
Time frame: Intraoperative (during cardiopulmonary bypass at predefined time points)
The primary outcome is the difference in Pearson correlation coefficients between BIS and PSI measured at predefined normothermic (36°C) and hypothermic (32°C) phases during cardiopulmonary bypass. Correlation coefficients will be calculated separately for each phase and compared using Fisher z-transformation to determine whether hypothermia alters the relationship between these indices.
3 secondary outcomes
Change in Bispectral Index (BIS) and Patient State Index (PSI) per Degree Celsius During Cooling and Rewarming
Time frame: Intraoperative (during cooling and rewarming phases of cardiopulmonary bypass)
Effect of CPB Initiation on the Relationship Between Bispectral Index (BIS) and Patient State Index (PSI)
Time frame: Intraoperative (comparison of pre-CPB and post-CPB initiation time points)
Agreement in Clinical Depth Categories Between Bispectral Index (BIS) and Patient State Index (PSI)
Time frame: Intraoperative (during predefined normothermic and hypothermic phases of cardiopulmonary bypass)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 19839944Meybohm P, Gruenewald M, Hocker J, Renner J, Graesner JT, Ilies C, Scholz J, Bein B. Correlation and agreement between the bispectral index vs. state entropy during hypothermic cardio-pulmonary bypass. Acta Anaesthesiol Scand. 2010 Feb;54(2):169-75. doi: 10.1111/j.1399-6576.2009.02138.x. Epub 2009 Oct 15.
- Background: PubMed 37469479Belletti A, Lee DK, Yanase F, Naorungroj T, Eastwood GM, Bellomo R, Weinberg L. Changes in SedLine-derived processed electroencephalographic parameters during hypothermia in patients undergoing cardiac surgery with cardiopulmonary bypass. Front Cardiovasc Med. 2023 Jul 4;10:1084426. doi: 10.3389/fcvm.2023.1084426. eCollection 2023.
- Individual participant dataSharing planned: Undecided. Individual participant data may be shared upon reasonable request, subject to approval by the institutional ethics committee and in accordance with applicable data protection regulations. At the time of registration, a definitive data sharing plan has not been finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYÇA TAŞ TUNA, Professor, M.D. principal investigator
Sakarya University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass and Hypothermia; Anesthesia, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Correlation Between Bispectral Index (BIS) and Patient State Index (PSI) Under Normothermic and Hypothermic Conditions (time frame: Intraoperative (during cardiopulmonary bypass at predefined time points)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07508579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.